Medical Device Malfunction - Customer Complaint - Response vs. Correction

Chrisx

Involved In Discussions
#1
When writing complaint response to customers, it is sometimes tempting to include additional information to avoid the device malfunction in the future. Is it likely that the FDA could interpret such a letter as a reportable correction under 21CFR806?
 
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R

randomname

#2
Don't know about the FDA, but if you have to provide additional information that may indicate that either the design is weak or the instructions for use are weak, or both.
 

shimonv

Trusted Information Resource
#3
Hi Chrisx,
There are three types of recalls:
• Class I - a situation in which there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death.
• Class II - a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
• Class III - a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.

Under 21 CFR 806, manufacturers and importers need not report events categorized as class III recalls under 21 CFR §7; only record keeping requirements would apply.

So, if the complaint is about a situation that is not likely to cause adverse health consequences (e.g. minor issue, routine service, normal ware) I do not think the agency will come after you or consider this as recall.

Keep in mind that your internal records - complaint investigation, risk management, etc. need to support you assessment.

Cheers,
Shimon
 
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